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Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee

Primary Purpose

Knee Osteoarthritis

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Amniotic Suspension Allograft
Placebo
Sponsored by
Organogenesis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Osteoarthritis, Knee, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Males or females 18 years of age or older
  2. Diagnosis of OA of the knee by a combination of clinical and radiographic findings
  3. OA of the knee with Kellgren and Lawrence radiographic classification (Grade 2-4 inclusive) confirmed by posterior-anterior, weight-bearing, fixed flexion radiography with 10° caudal beam angulation. A specially designed positioning frame will be used to standardize the positioning for image acquisition.
  4. Patients who have failed to adequately respond for at least 6 months to at least 2 OA therapies that include conservative, non-pharmacological therapy and simple analgesics (e.g., acetaminophen); nonsteroidal anti-inflammatory drugs (NSAIDS); avoidance of activities that cause joint pain; exercise; weight loss; physical therapy; and removal of excess fluid from the knee
  5. Overall pain score over the previous 7 days of 11 or more on the WOMAC Pain scale.
  6. Body mass index (BMI) < 40 kg/m²
  7. If female, must be postmenopausal (for at least 2 years), surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), sexually abstinent, or willing and able to use 2 methods of contraception from Day 1 through 12 months after treatment
  8. Males who are not surgically sterile (vasectomy) for at least 6 months prior to screening must confirm their willingness to use adequate methods of contraception from Day 1 through 12 months after treatment
  9. Willing to agree not to use illicit drugs during the study, and to have illicit drug testing at screening and at later time points, if illicit drug use is suspected during the study
  10. Able to comply with study requirements and complete the full sequence of protocol-related procedures and evaluations, including post-hospitalization, out-patient, and follow-up visits
  11. Able to understand and provide written informed consent

Exclusion Criteria:

  1. Use of pain medication (including NSAIDs and cannabidiol [CBD] oil) less than 15 days before treatment (acetaminophen allowed)
  2. Regular use of anticoagulants
  3. Symptoms of locking, intermittent block to range of motion, or loose body sensation that could indicate meniscal displacement or an IA loose body
  4. Corticosteroid injection into the index knee within 3 months prior to screening
  5. Viscosupplement (e.g., hyaluronic acid [HA]) injection, platelet-rich plasma injection, bone marrow aspirate (BMA) or bone marrow aspiration concentrate (BMAC), placental-derived tissue/cells, adipose tissue, or any other autologous or allogeneic product into the index knee within 6 months prior to screening
  6. Patients with known hypersensitivity reactions to ASA or any of its constituents (e.g., HA, dimethyl sulfoxide [DMSO])
  7. Knee surgery on the index knee within 12 months prior to screening and/or planned knee surgery during the study
  8. Knee surgery on the contralateral knee within 6 months prior to screening and/or planned knee surgery during the study
  9. Acute index knee trauma within 3 months prior to screening
  10. Knee effusion requiring aspiration of the index or contralateral knee within 3 months prior to screening
  11. Contralateral knee pain ≥ 4 on the WOMAC Pain scale on most days during the past week.
  12. Current therapy with any immunosuppressive therapy, including corticosteroids (> 5 mg/day of prednisone)
  13. Clinically significant findings on the screening laboratory tests or physical examination that are not specific to OA of the knee and may interfere with study conduct or interpretation of data or increase patient risk
  14. Clinically significant intercurrent illness, medical condition, non-knee pain, or medical history (including neurological or mental illness, human immunodeficiency virus, fibromyalgia, complex regional pain syndrome, or any active infection, including hepatitis B or C) that could jeopardize the patient safety, limit participation, or compromise interpretation of data derived from the patient
  15. Active alcohol or substance use disorder, or any other reason that would make it unlikely for the patient to comply with study procedures
  16. Females who are pregnant (positive pregnancy test at screening or prior to treatment) or lactating
  17. Participation in another clinical trial within the 30 days (or 5 half-lives of the investigational compound, whichever is longer) before screening

Sites / Locations

  • Central Research Associates
  • Alabama Clinical Therapeutics
  • AMR Mobile
  • Arizona Arthritis & Rheumatology Research
  • Fiel Family & Sports Medicine/ CCT Research
  • Arizona Arthritis & Rheumatology Research
  • Tri West Research Associates
  • Horizon Clinical Research Center
  • Actca, A Member of the Allliance Inc.
  • University of California at Los Angeles
  • Stanford Medicine
  • University of California at Davis
  • AARDS Research, Inc.
  • Gulfcoast Research Institute
  • Pinnacle Trials, Inc.
  • Injury Care Research
  • Chicago Clinical Research Institute Inc
  • Rush University Medical Center
  • Affinity Health
  • Sinai Hospital of Baltimore
  • Klein & Associates, MD, PA
  • Tufts Medical Center
  • Methodist Physicians Clinic/ CCT Researc
  • Physician Research Collaboration
  • NYU Langone Health
  • Hospital for Special Surgery
  • Lenox Hill Hospital (Northwell Health)
  • M3 Emerging Medical Research, LLC
  • Moore Orthopedics and Sports Medicine
  • M3 Emerging Medical Research, LLC
  • Lehigh Center for Clinical Research
  • University Orthopedics Center
  • University Orthopedic Center
  • PCPMG Clinical Research Unit, LLC
  • Coastal Carolina Research Center
  • Affinity Health
  • Cedar Health Research, LLC
  • Spectrum Medical, Inc

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ASA

Placebo

Arm Description

Participants receive a single IA injection of 2 mL of ASA (plus 2 mL of normal saline)

Participants receive a single IA injection of 4 mL of normal saline

Outcomes

Primary Outcome Measures

The difference in change from baseline in WOMAC Pain scale at 6 months between ASA- and placebo-treated patients
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.

Secondary Outcome Measures

The difference between changes from baseline for ASA- and placebo- treated patients in WOMAC Function at 6 months
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
The difference between changes from baseline for ASA- and placebo-treated patients in the OMERACT-OARSI responder rate at 6 months
Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International. (OMERACT-OARSI) Responders are defined as participants with high improvement in pain or function.
The difference between changes from baseline for ASA- and placebo-treated patients in WOMAC Pain at 3 months
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
The difference between changes from baseline for ASA- and placebo- treated patients in non-inferiority of WOMAC Function at 3 months
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
The difference between changes from baseline for ASA- and placebo-treated patients in the OMERACT-OARSI responder rate at 3 months
Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International. (OMERACT-OARSI) Responders are defined as participants with high improvement in pain or function.
The difference between changes from baseline for ASA- and placebo-treated patients in the WOMAC Total at 6 months
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
The difference between ASA- and placebo-treated patients in the WOMAC Stiffness at 6 months
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
The difference between changes from baseline for ASA- and placebo- treated patients in the WOMAC Total at 3 months
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
The difference between changes from baseline for ASA- and placebo-treated patients in the WOMAC Stiffness at 3 months
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Incidence of adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study patient administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. This includes any occurrence that is new in onset or aggravated in severity or frequency from the baseline condition, or abnormal result of diagnostic procedures, including clinical laboratory test abnormalities.

Full Information

First Posted
November 5, 2020
Last Updated
August 9, 2023
Sponsor
Organogenesis
Collaborators
Premier Research Group plc
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1. Study Identification

Unique Protocol Identification Number
NCT04636229
Brief Title
Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee
Official Title
A Phase 3 Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy of Amniotic Suspension Allograft (ASA) in Patients With Osteoarthritis of the Knee
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 14, 2020 (Actual)
Primary Completion Date
August 15, 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organogenesis
Collaborators
Premier Research Group plc

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is being conducted to evaluate the efficacy and safety of ASA compared to placebo in the management of osteoarthritis (OA) symptoms of the knee.
Detailed Description
This is a prospective, multicenter, randomized, double-blind, placebo-controlled Phase 3 study of ASA in patients with OA of the knee. Initially, 474 subjects are planned for inclusion in this study using a group sequential design with two interim analyses and a final analysis. Sample size re-estimation is planned at the second interim analysis. Based on conditional power, the maximum sample size may be increased to up to 700 patients. Patients will be randomly assigned in a 1:1 ratio to receive a single intra-articular (IA) injection of 2 mL of ASA (plus 2 mL of normal saline) or 4 mL of normal saline. Patients will be screened after informed consent is obtained. Eligible patients will be randomized to receive a single IA injection on Day 1. They will have serial assessments of knee pain, function, and symptoms scores, as well as safety assessments for up to 52 weeks after administration of the study drug. The planned sequence and maximum duration of the study periods will be as follows: Screening: 2 weeks Treatment: 1 day Follow-up: 52 weeks The maximum treatment duration for each patient is 1 day. The maximum study duration for each patient is 54 weeks. Efficacy will be assessed via Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) responder rates. Safety will be assessed via monitoring of adverse events (AEs), safety laboratory testing, vital signs, physical examination, and concomitant medication use. An independent data monitoring committee (DMC) with a defined charter will review study data and make preliminary decisions relative to interim analyses. The assessments that are used in this study are standard, and are generally recognized as reliable, accurate, and relevant. No pediatric patients will be included as OA of the knee is an age-related disorder and rarely occurs in patients under the age of 18 years. The sponsor plans to submit a waiver for studies in all pediatric age subgroups.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Osteoarthritis, Knee, Arthritis, Joint Diseases, Musculoskeletal Diseases, Rheumatic Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
This is a prospective, multicenter, randomized, double-blind, placebo-controlled study of ASA in patients with OA of the knee. Patients will be randomly assigned in a 1:1 ratio to receive a single IA injection of 2 mL of ASA (plus 2 mL of normal saline) or 4 mL of normal saline.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
All clinic staff who may be involved in making assessments of safety will be blinded to treatment assignment.
Allocation
Randomized
Enrollment
474 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ASA
Arm Type
Experimental
Arm Description
Participants receive a single IA injection of 2 mL of ASA (plus 2 mL of normal saline)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants receive a single IA injection of 4 mL of normal saline
Intervention Type
Biological
Intervention Name(s)
Amniotic Suspension Allograft
Intervention Description
This investigational product is a cryopreserved product derived from human amnion and cells from the amniotic fluid.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo is 0.9% normal saline: 4 mL to be injected IA.
Primary Outcome Measure Information:
Title
The difference in change from baseline in WOMAC Pain scale at 6 months between ASA- and placebo-treated patients
Description
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time Frame
Baseline to Week 26
Secondary Outcome Measure Information:
Title
The difference between changes from baseline for ASA- and placebo- treated patients in WOMAC Function at 6 months
Description
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time Frame
Baseline to Week 26
Title
The difference between changes from baseline for ASA- and placebo-treated patients in the OMERACT-OARSI responder rate at 6 months
Description
Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International. (OMERACT-OARSI) Responders are defined as participants with high improvement in pain or function.
Time Frame
Baseline to Week 26
Title
The difference between changes from baseline for ASA- and placebo-treated patients in WOMAC Pain at 3 months
Description
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time Frame
Baseline to Week 12
Title
The difference between changes from baseline for ASA- and placebo- treated patients in non-inferiority of WOMAC Function at 3 months
Description
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time Frame
Baseline to Week 12
Title
The difference between changes from baseline for ASA- and placebo-treated patients in the OMERACT-OARSI responder rate at 3 months
Description
Outcome Measures in Rheumatoid Arthritis Clinical Trials - Osteoarthritis Research Society International. (OMERACT-OARSI) Responders are defined as participants with high improvement in pain or function.
Time Frame
Baseline to Week 12
Title
The difference between changes from baseline for ASA- and placebo-treated patients in the WOMAC Total at 6 months
Description
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time Frame
Baseline to Week 26
Title
The difference between ASA- and placebo-treated patients in the WOMAC Stiffness at 6 months
Description
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time Frame
Baseline to Week 26
Title
The difference between changes from baseline for ASA- and placebo- treated patients in the WOMAC Total at 3 months
Description
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time Frame
Baseline to Week 12
Title
The difference between changes from baseline for ASA- and placebo-treated patients in the WOMAC Stiffness at 3 months
Description
The Western Ontario and McMaster Universities (WOMAC®) Osteoarthritis Index is a questionnaire that measures pain, stiffness, and function both independently and collectively, using a Likert 3.1, 5-point scale. The Likert Scale uses the following descriptors for all items: none, mild moderate, severe, and extreme, corresponding to an ordinal scale of 0-4. Higher scores on the WOMAC indicate worse pain, stiffness, and functional limitations.
Time Frame
Baseline to Week 12
Title
Incidence of adverse events (AEs)
Description
An AE is any untoward medical occurrence in a clinical study patient administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal finding), symptom, or disease temporally associated with the use of a medicinal (investigational or non-investigational) product, whether or not related to that medicinal (investigational or non-investigational) product. This includes any occurrence that is new in onset or aggravated in severity or frequency from the baseline condition, or abnormal result of diagnostic procedures, including clinical laboratory test abnormalities.
Time Frame
Baseline to Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males or females 18 years of age or older Diagnosis of OA of the knee by a combination of clinical and radiographic findings OA of the knee with Kellgren and Lawrence radiographic classification (Grade 2-4 inclusive) confirmed by posterior-anterior, weight-bearing, fixed flexion radiography with 10° caudal beam angulation. A specially designed positioning frame will be used to standardize the positioning for image acquisition. Patients who have failed to adequately respond for at least 6 months to at least 2 OA therapies that include conservative, non-pharmacological therapy and simple analgesics (e.g., acetaminophen); nonsteroidal anti-inflammatory drugs (NSAIDS); avoidance of activities that cause joint pain; exercise; weight loss; physical therapy; and removal of excess fluid from the knee Overall pain score over the previous 7 days of 11 or more on the WOMAC Pain scale. Body mass index (BMI) < 40 kg/m² If female, must be postmenopausal (for at least 2 years), surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), sexually abstinent, or willing and able to use 2 methods of contraception from Day 1 through 12 months after treatment Males who are not surgically sterile (vasectomy) for at least 6 months prior to screening must confirm their willingness to use adequate methods of contraception from Day 1 through 12 months after treatment Willing to agree not to use illicit drugs during the study, and to have illicit drug testing at screening and at later time points, if illicit drug use is suspected during the study Able to comply with study requirements and complete the full sequence of protocol-related procedures and evaluations, including post-hospitalization, out-patient, and follow-up visits Able to understand and provide written informed consent Exclusion Criteria: Use of pain medication (including NSAIDs and cannabidiol [CBD] oil) less than 15 days before treatment (acetaminophen allowed) Regular use of anticoagulants Symptoms of locking, intermittent block to range of motion, or loose body sensation that could indicate meniscal displacement or an IA loose body Corticosteroid injection into the index knee within 3 months prior to screening Viscosupplement (e.g., hyaluronic acid [HA]) injection, platelet-rich plasma injection, bone marrow aspirate (BMA) or bone marrow aspiration concentrate (BMAC), placental-derived tissue/cells, adipose tissue, or any other autologous or allogeneic product into the index knee within 6 months prior to screening Patients with known hypersensitivity reactions to ASA or any of its constituents (e.g., HA, dimethyl sulfoxide [DMSO]) Knee surgery on the index knee within 12 months prior to screening and/or planned knee surgery during the study Knee surgery on the contralateral knee within 6 months prior to screening and/or planned knee surgery during the study Acute index knee trauma within 3 months prior to screening Knee effusion requiring aspiration of the index or contralateral knee within 3 months prior to screening Contralateral knee pain ≥ 4 on the WOMAC Pain scale on most days during the past week. Current therapy with any immunosuppressive therapy, including corticosteroids (> 5 mg/day of prednisone) Clinically significant findings on the screening laboratory tests or physical examination that are not specific to OA of the knee and may interfere with study conduct or interpretation of data or increase patient risk Clinically significant intercurrent illness, medical condition, non-knee pain, or medical history (including neurological or mental illness, human immunodeficiency virus, fibromyalgia, complex regional pain syndrome, or any active infection, including hepatitis B or C) that could jeopardize the patient safety, limit participation, or compromise interpretation of data derived from the patient Active alcohol or substance use disorder, or any other reason that would make it unlikely for the patient to comply with study procedures Females who are pregnant (positive pregnancy test at screening or prior to treatment) or lactating Participation in another clinical trial within the 30 days (or 5 half-lives of the investigational compound, whichever is longer) before screening
Facility Information:
Facility Name
Central Research Associates
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Alabama Clinical Therapeutics
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
AMR Mobile
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Research
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Fiel Family & Sports Medicine/ CCT Research
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Arizona Arthritis & Rheumatology Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Tri West Research Associates
City
El Cajon
State/Province
California
ZIP/Postal Code
92020
Country
United States
Facility Name
Horizon Clinical Research Center
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Actca, A Member of the Allliance Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
University of California at Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford Medicine
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Name
University of California at Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95186
Country
United States
Facility Name
AARDS Research, Inc.
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Gulfcoast Research Institute
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
Pinnacle Trials, Inc.
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Injury Care Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83713
Country
United States
Facility Name
Chicago Clinical Research Institute Inc
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Affinity Health
City
Oak Brook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Klein & Associates, MD, PA
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Methodist Physicians Clinic/ CCT Researc
City
Fremont
State/Province
Nebraska
ZIP/Postal Code
68025
Country
United States
Facility Name
Physician Research Collaboration
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68516
Country
United States
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Lenox Hill Hospital (Northwell Health)
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
M3 Emerging Medical Research, LLC
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Moore Orthopedics and Sports Medicine
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
M3 Emerging Medical Research, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Lehigh Center for Clinical Research
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
University Orthopedics Center
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
University Orthopedic Center
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
PCPMG Clinical Research Unit, LLC
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29501
Country
United States
Facility Name
Coastal Carolina Research Center
City
North Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Affinity Health
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Cedar Health Research, LLC
City
Burleson
State/Province
Texas
ZIP/Postal Code
76028
Country
United States
Facility Name
Spectrum Medical, Inc
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://pubmed.ncbi.nlm.nih.gov/31533151/
Description
Farr J, et al. A randomized controlled single-blind study demonstrating superiority of ASA injection over hyaluronic acid and saline control for modification of knee OA symptoms. J Knee Surg. 2019; https://doi.org/10.1055/s-0039-1696672.

Learn more about this trial

Efficacy of Amniotic Suspension Allograft in Patients With Osteoarthritis of the Knee

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